CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report

REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow recalled

Westmed is recalling REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 090820N30

Quantity recalled6000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0746-2021
FDA event ID: 86903
Recalling firm: Westmed, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2020
FDA classified: 29 Dec 2020
Reported: 6 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

11 Nov 2020	Recall initiated by company
29 Dec 2020	Classified by FDA	+48 days
6 Jan 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.

Product as listed by the FDA

REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

Nationwide California Colorado Illinois Kansas Maryland Minnesota Missouri Ohio Oklahoma Pennsylvania Rhode Island Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot # 090820N30

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 86903

Reported	Class	Recall	Company	Reason	Where
6 Jan 2021	CLASS II	REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended recalled	Westmed	Other	Nationwide
6 Jan 2021	CLASS II	REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut recalled	Westmed	Other	Nationwide
6 Jan 2021	CLASS II	REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask recalled	Westmed	Other	Nationwide
6 Jan 2021	CLASS II	REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" recalled	Westmed	Other	Nationwide
6 Jan 2021	CLASS II	Disposable Respiratory Products Non-rebreather Mask recalled by Westmed	Westmed	Other	Nationwide

More recalls from Westmed

All 24

Reported	Class	Recall	Company	Reason	Where
6 Nov 2024Device	CLASS II	Flex Extenders, 5.2" OD ID recalled by Westmed	Westmed	Packaging Defects	30 states
6 Jan 2021Device	CLASS II	Disposable Respiratory Products Non-rebreather Mask recalled by Westmed	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" recalled	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask recalled	Westmed	Other	Nationwide
6 Jan 2021Device	CLASS II	REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut recalled	Westmed	Other	Nationwide

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